DLG Naturals, Inc. – FDA Warning Letter, Oct 6, 2021

The FDA conducted an inspection of DLG Naturals, Inc. in Janesville, Wisconsin, on September 23, 28, and October 6, 2021, and reviewed their website in March 2022. The inspection revealed that DLG Naturals' products "Nilotica East African Shea Butter," "Kalahari Melon Seed Oil," "Baobab Oil," and Zuplex Botanicals’ "Kigelia Africana Fruit Extract" (also marketed as "Kigafirm") are unapproved new drugs, violating sections 505(a) and 301(d) of the FD&C Act.

These products are deemed drugs under section 201(g)(1) due to claims on the company's website, www.dlgnaturals.com, indicating their use for disease treatment, prevention, or affecting body structure/function. Examples of claims include "anti-inflammatory, anti-cancer, and anti-bacterial" properties for Baobab Oil, "healing properties to the skin" for Kalahari Melon Seed Oil, and "alleviating rheumatism, reduction of dermatitis, strong anti-aging action" for Nilotica East African Shea Butter. Kigelia Africana Fruit Extract was marketed for "firming and anti-inflammatory activity" and traditional uses for "eczema, fungal infections, psoriasis and boils."

Since these products are not generally recognized as safe